The guideline issued by the FDA is regulatory flexibility, including a temporary waiver of the premarket notification requirements under Section 510 (k) of the Food, Drug, and Cosmetic Act.
Are you a manufacturer of medical devices and need an overview or have specific questions about approval, reimbursement or testing? Do you need a quality management system according to EN ISO 13485? The complexity of regulatory requirements harbours the risk of getting lost and taking the wrong path.
BEO BERLIN helps you to define the next steps and explains what must not be overlooked.